Data Management within a Contract Research Organization

1. Data Management within a Contract Research Organization Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Premier Laboratory, LLC

2. Objectives Discuss how a histology contract laboratory implemented digital scanning capabilities (Aperio Scanscope) along with a web-based data management system (Spectrum Plus) to increase the level of customer service and quality of work we provide to our clients.

3. Our Initial Goals Initially purchased scan scope to create whole slide digital images • Primary focus was due to the increasing number of image analysis projects we were working on • Image capture was labor intensive and quality and appropriate selection of images depended upon the level of training and education of the individual taking the images • Lots of merged images in Adobe Elements (not ideal) • Image analysis capabilities and whole slide image analysis was intriguing and a way increase quality of data • Revenue stream, set us apart from other CRO’s

4. The Learning Curve • The more time we spent working with both the scan scope and the spectrum plus data base the more we saw how this could really impact the level of service and level of quality we could provide to our clients • It was a great match for us since our business core values was to provide a quality product with an increased level of customer service we can provide our clients

5. Basic Services • Receive slides, scan slides, burn DVD’s, ship slides and DVD’s back to client • #1 and place slides up on Spectrum for approximately 30 days • #1 and place slides up on Spectrum indefinitely

6. Security of Remote Log In • With Spectrum Plus we are able to create secure user ID’s and passwords for each separate client • When a client logs in they are only have access to their images • In administrative functions we can select how much control each user has • Managing client confidentiality • Its really EASY!

7. Scanning for other CRO’s Some of our clients are other CRO’s so they have clients also and their clients also want to be able to view the images. • the CRO does not need to give out their user ID and password (potentially see other clients images) • create a user ID and password for the client of the CRO and then give the CRO access to those images

8. as administrator we have control over all accounts, we are • able to add, delete or change user accounts – keep an excel • spreadsheet of user ID’s and passwords, clients can not change • passwords • users are only able to access their images and can not make • any changes to their account • there are different levels of control – no access, read only and • full control • most clients have full control - able to take snapshots, create • annotations, take measurments.

9. Client Training - Minimal • Accessing images through spectrum is very easy. • Send off an e-mail to the client with basic instructions • Provide additional training if required • phone conversation • E-mail • “Go to meeting” • Digital conferencing – Spectrum Feature

10. The scanned images of your slides are on our server. Please follow the instructions below to gain access to your images. • You will need to download the free shareware from Aperio from the following link, you do not need to fill in any info if you choose not to just click the download now button http://www.aperio.com/download.asp • To gain access to your images you will need to go to the following IP address; http://mail.premierlab.com • The Spectrum Page should come up: • your username is: SamplesSlides (this is case sensitive) • your password is: premier • The software is relatively user friendly, but if you have any questions please feel free to contact us.

11. Increased Customer Service Routine protocol development Clients have immediate access to images during the development stages. They have the ability to essentially QC check our process. Increases communication between us and the clients which will increase customer service and satisfaction. • review results of pilot samples • check for proper orientation • check for correct area of interest • check for correct staining patterns

12. Case Study #1 Client submitted rat brain sections, already trimmed to a specific area of interest. They wanted CEV staining of both the anterior and posterior hippocampus at specific levels • processed to paraffin cut 4 levels initially • scanned slides • client was able to view slides and direct us Review on Spectrum

13. Immunohistochemical Protocol Development Great way to work with clients during immunohistochemical protocol development • Immediate access to results from titer studies • Spectrum allows us to upload documents • Antibody development spreadsheet • Final protocol if necessary • Methods for publications • Antibody specification sheets

14. Case Study #2 Client wanted us to develop several antibodies on mouse collagen arthritis sections • able to review all slides, annotate areas of interest or concern, take snapshots • able to access our development methods • able to access our final protocol • able to access materials and methods for publications Review on Spectrum

15. Data from Entire Project is Available on Spectrum • Projects may consist of multiple types of samples with varying analysis methods • data from aperio algorithms linked to slide • images captured from methods other than the aperio or from other analysis methods • data from the project • report, tables, graphs, gross images, procedures, etc. all can be uploaded to Spectrum

16. Case Study #3 Multiple analysis in a femoral artery balloon injury model in rabbits. Looked at frozen sections, paraffin sections and “En Face” analysis of the Thoracic Aorta. Since all of the data and images is located in one spot it makes it easy to review data and draft reports Review on Spectrum

17. Case Study #4 Muscular Dystrophy Model – Mdx Mice • Receive multiple muscles from Mdx mice • Multiple analysis parameters • Pathology (inflammation, fibrosis, myodystrophy) • Centrally localized nuclei and atrophied cell counts • Fiber diameter, fiber area, etc. Review on Spectrum

18. Case Study #5 DHE (supraoxide staining) of mouse femoral arteries, frozen sections, ethidium bromide cube for fluorescence. • uploaded fluorescence captured tiff images into the spectrum data • analyzed via batch analysis through spectrum and Aperio’s algorithms • calculated intensity of staining

19. Summary • Immediate access to images • Upload images not generated with ScanScope • Upload data or other files related to the study • Easy way to review all data associated with a particular project Implementation of whole slide digital imaging along with the Spectrum Plus database has allowed us to expand our services, improve the quality of services we provide to our clients and also increase the level of customer service.

20. A big thanks to Aperio and everyone back in the lab. Without either of them I would not have had the opportunity to give this presentation.